SonoVue®

 

A quality product from Bracco Imaging

 

As a result of many years of research and development conducted within Bracco, SonoVue® is a second-generation ultrasound contrast agent designed and optimized with regard to the resistance to pressure. The research has led to the selection of SF6, a gas with a low solubility in blood for the gaseous phase of the microbubbles and to a phospholipidic monolayer for the shell1, 2, 3.

SonoVue® was first approved in the European Union under the centralised procedure on 26 March 2001 and is currently marketed in 36 countries worldwide.

 

Today SonoVue® can boast more than 1,000 peer review journal articles in the life sciences4.

Physicochemical Characteristics

 

ready-to-use suspension / vial 5 ml
number of microbubbles / ml suspension approx. 2 · 108
gas content (SF 6) / ml suspension 8 μl
mean diameter of microbubbles approx. 2,5 μm
size range of microbubbles 1 - 11 μm (90% < 6 μm, 99% <11 μm)
osmolality approx. 290 mOsmol / Kg
viscosity < 2 mPa · s
pH-value 4,5 - 7,5
stability after preparation 6 hours

 

Presentation

 

SonoVue® is presented as a kit. The needleless kit includes all the necessary material for

 

SonoVue® preparation:

 

  • 5 ml saline 0.9% pre-filled syringe
     
  • a minispike
     
  • a vial containing gas and lyophilized powder.

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Different countries may have specific processes in place to handle reports of adverse reactions. To report an adverse reaction related to Bracco products, you can find specific contacts and information selecting the page "Pharmacovigilance" of your country.

DISCLAIMER

 

SonoVue should not be administered to patients with known hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.

 

SonoVue is contraindicated in patients known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure > 90 mmHg), uncontrolled systemic hypertension, and in patients with adult respiratory distress syndrome.

 

Sonovue should not be used in combination with dobutamine in patients with conditions suggesting cardiovascular instability where dobutamine is contraindicated.

 

The safety and efficacy of SonoVue have not been established in pregnant and lactating women therefore, SonoVue should not be administered during pregnancy and lactation (see Section 4.6).